Insertion Device and Method for Delivery of a Mesh Carrier

ABSTRACT

An insertion device includes an elongate member and a stylet. The elongate member has a proximal end portion, a distal end portion, and defines a lumen therethrough. The stylet has a proximal end portion, a distal end portion, and is slidably coupled to the elongate member. The stylet is configured to move from a first position to a second position with respect to the elongate member. The proximal end portion of the stylet is configured to removably couple a mesh carrier thereto. A portion of the proximal end portion of the stylet is disposed outside of the lumen of the elongate member when the stylet is in its first position and is disposed within the lumen when the stylet is in its second position.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/120,105, entitled “Insertion Device and Method for Deliveryof a Mesh Carrier,” filed Dec. 5, 2008, the disclosure of which ishereby incorporated by reference in its entirety.

BACKGROUND

The disclosed embodiments relate generally to medical devices and moreparticularly to an insertion device for delivery of a mesh carrier intoa body of a patient.

The disclosed embodiments have application to a wide variety of surgicalprocedures. For example, one such procedure is directed to urinaryincontinence and includes fixing an implant to tissue within a body of apatient to provide support for the urethra. Another such procedureincludes fixing an implant to bodily tissue of a patient to support abladder of the patient.

Mesh carriers may be placed within a body of a patient to provideanchoring points for medical implants. In some procedures, it isnecessary for a practitioner, such as a physician, to insert a meshcarrier into bodily tissue of the patient at a location not easilyvisible or accessible to the practitioner. For example, some locationsare not visible or easily accessible due to internal obstructions, suchas the pubic bone. Known insertion devices can be used to position amesh carrier at a first location within bodily tissue and to fix themesh carrier to the tissue. However, in such procedures where thelocation is not easily visible or easily accessible, it may be difficultto maneuver the known insertion device around such obstructions anddelivering the mesh carrier to a desired location in bodily tissue.Furthermore, the practitioner may require a larger incision at theincision site in order to allow ample room to rotate and/or pivot theknown insertion device within the body in order to reach the desiredlocation. In such an instance, the rotating and/or pivoting of themedical device may cause unintended stretching or tearing of tissue.Additionally, it may become necessary to remove the known insertiondevice from the body to better position it at the incision site.Unnecessary insertion, over-insertion, or excessive rotation could,therefore, induce trauma to the patient.

Thus, a need exists for an insertion device that has a configurationthat facilitates insertion of an implant or a mesh carrier for animplant. For example, a need exists for an insertion device thatfacilitates insertion around or behind an internal obstruction, such asthe pubic bone.

SUMMARY

In some embodiments, an insertion device includes an elongate member anda stylet. The elongate member has a proximal end portion, a distal endportion, and defines a lumen therethrough. The elongate member includesa curved portion between the proximal end portion and the distal endportion. In some embodiments, the distal end portion is configured toremovably couple a mesh carrier thereto. The proximal end portionincludes a handle defining a longitudinal axis. The stylet has aproximal end portion, a distal end portion, and is configured to movefrom a first position to a second position with respect to the elongatemember. The stylet is configured to engage the mesh carrier to removethe mesh carrier from the elongate member such that a longitudinal axisdefined by the mesh carrier is substantially orthogonal to thelongitudinal axis defined by the handle.

In other embodiments, the elongate member has a proximal end portion, adistal end portion, and defines a lumen therethrough. The proximal endportion of the elongate member defines an axis substantially orthogonalto an axis defined by the distal end portion of the elongate member. Thestylet has a proximal end portion and a distal end portion. At least aportion of the stylet is disposed within the lumen of the elongatemember. The stylet is coupled to the elongate member such that thestylet is configured to move from a first position to a second positionwith respect to the elongate member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an insertion device according toone embodiment.

FIG. 2 is side perspective view of an insertion device coupled to a meshcarrier with a stylet in a first position according to anotherembodiment.

FIG. 3 is a side perspective view of the insertion device of FIG. 2 withthe stylet in a second position.

FIG. 4 is a side perspective view of the insertion device of FIG. 2 withthe stylet removing the mesh carrier.

FIG. 5 is a partial cross-sectional view of the insertion device of FIG.2.

FIG. 6 is a cross-sectional view of a distal end portion of theinsertion device of FIG. 2.

FIG. 7 is a cross-sectional view of a distal end portion of theinsertion device of FIG. 3.

FIG. 8 is a cross-sectional view of a distal end portion of theinsertion device of FIG. 2 removing the mesh carrier.

FIG. 9 is a partial cross-sectional view of the insertion device of FIG.2 with a first portion of a handle removed.

FIG. 10 is an exploded view of a portion of the insertion device of FIG.2.

FIG. 11 is a side view of a portion of the insertion device of FIG. 2.

FIG. 12 is a cross-sectional view of the portion of the insertion deviceof FIG. 11 along line 12-12, with a stylet in a first position.

FIG. 13 is a cross-sectional view of the portion of the insertion deviceof FIG. 11 along line 12-12, with a stylet in a second position.

FIG. 14 is a bottom, partial cross-sectional view of the insertiondevice of FIG. 2.

FIG. 15 is an end, partial cross-sectional view of the insertion deviceof FIG. 2.

FIG. 16 is a side view of a mesh carrier according to an embodiment.

FIG. 17 is a perspective view of the mesh carrier of FIG. 16.

FIG. 18 is a side view of a distal end portion of the insertion deviceof FIG. 2 and a filament

FIG. 19 is a cross-sectional view of the insertion device and filamentof FIG. 18.

FIG. 20 is a side view of an embodiment of an implant positioned withina body of a patient.

FIG. 21 is a side view of an distal end portion of the insertion deviceaccording to another embodiment.

FIG. 22 is a cross-sectional view of the insertion device of FIG. 21along line 23-23 with a stylet in a first position.

FIG. 23 is a cross-sectional view of the insertion device of FIG. 21along line 23-23, with a stylet in a second position.

FIG. 24 is a flowchart of a method according to an embodiment.

FIGS. 25-27 illustrate locations within the female pelvic region inwhich an insertion device can be inserted.

DETAILED DESCRIPTION

The insertion device and mesh carrier described herein can be insertedinto a body of a patient, such as into bodily tissue. For example, theinsertion device can be configured to deliver a first mesh carrierconfigured to selectively retain an implant (also referred to herein asa “filament”, “tape”, “implant”, “mesh”, “sling”, or “strap”) withrespect to a bodily tissue. A plurality of such mesh carriers can beanchored within the body of a patient at spaced locations whileretaining a filament between the plurality of mesh carriers to providesupport for other portions of the body (e.g., organs or portions oforgans).

The insertion device is configured to place, deposit, or otherwiseinsert a mesh carrier into a bodily tissue of a patient. The filament isconfigured to suspend or support a bodily tissue or organ when thefilament is retained within the patient by one mesh carrier. Thus, inone embodiment, the insertion device can place the mesh carrier into theobturator externus muscle for incontinence treatment. Specifically,first and second mesh carriers are each placed in opposing obturatorexternus muscles of a patient and the filament is extended between thefirst and second mesh carriers to form a sling to provide support to theurethra or bladder neck of the patient. The insertion device can be avariety of different configurations and can have a variety of differentcomponents.

As used in this specification, the words “proximal” and “distal” referto the direction closer to and further away from, respectively, anoperator (e.g., surgeon, physician, nurse, technician, etc.) who woulduse an insertion device or a therapeutic device during a procedure. Forexample, the end of an insertion device first to contact the patient'sbody would be the distal end, while the opposite end of the insertiondevice (e.g., the end of the insertion device being operated by theoperator) would be the proximal end of the insertion device. Similarly,the end of a insertion device implanted the furthest within thepatient's body would be the distal end, while the opposite end of theinsertion device (e.g., the end of the insertion device that is insertedthe least amount within the body or the end of the insertion device thatis disposed outside of the body) would be the proximal end.

FIG. 1 is a schematic illustration of an insertion device 100 accordingto an embodiment of the invention. The insertion device 100 can beinserted into a body of a patient, such as into bodily tissue.

The insertion device 100 has a proximal end portion 102 and a distal endportion 104. The insertion device 100 includes an elongate member 110, astylet (not shown in FIG. 1), and a handle 170. At least a portion ofthe elongate member 110 and the stylet are configured to be insertedinto a body of a patient. The elongate member 110 includes a proximalend portion 112 and a distal end portion 113. In some embodiments, theproximal end portion 112 of the elongate member 110 is configured to beslidably coupled to the handle 170. The distal end portion 113 of theelongate member 110 is configured to be coupled to a mesh carrier 190.In some embodiments, the elongate member 110 includes a curved portion111 between the proximal end portion 112 and the distal end portion 113.The curved portion 111 is configured such that an axis XX-XX defined bythe proximal end portion 112 of the elongate member 110 is substantiallyorthogonal to an axis YY-YY defined by the distal end portion 113 of theelongate member 110 and is substantially orthogonal to a longitudinalaxis defined by the mesh carrier 190 when the mesh carrier 190 isdelivered into bodily tissue. In such embodiments, the curved portion111 facilitates insertion of the device 100 around or behind an internalobstruction, such as the pubic bone, and allows more control whendelivering the mesh carrier 190 into bodily tissue. Furthermore, curvedportion 111 can define a radius of curvature of any suitable length. Forexample, the radius of curvature can be 1.0 inch, 1.1 inches, 1.5inches, or 2 inches.

The handle 170 is slidably coupled to the proximal end portion 112 ofthe elongate member 110 and is fixedly coupled to the proximal endportion of the stylet. The handle 170 is configured to move the styletrelative to the elongate member 110.

Although a mesh carrier 190 is used with insertion device 100 asdescribed in the above disclosed embodiment, it should be understoodthat in some embodiments, a tissue anchor can be used.

FIGS. 2-15, 18, and 19 illustrate one embodiment of an insertion device.Insertion device 200 includes a proximal end portion 202 and a distalend portion 204. The insertion device 200 includes an elongate member210, a handle 270, and a stylet 230. The elongate member 210 and stylet230 are configured to be at least partially inserted into a body of apatient.

The elongate member 210 includes a proximal end portion 212, a distalend portion 213, and defines a lumen 218 (shown, for example in FIGS.5-10) extending therethrough. The lumen 218 is configured to receive atleast a portion of the stylet 230.

As shown in FIGS. 2-5 and 9-14, the proximal end portion 212 of theelongate member 210 is coupled to a coupling member 250 and defines afirst axis A-A. The coupling member 250 includes a distal end portion252, a proximal end portion 254 (shown, for example, in FIGS. 3, 9, 10,12, and 13), and defines a lumen therethrough (shown in FIGS. 12 and 13)configured to fixedly receive at least a portion of the elongate member210. Thus, the coupling member 250 is configured to be fixedly disposedabout the portion of the elongate member 210 and is configured to bemoved such that the coupling member 250 moves the elongate member 210relative to the stylet 230.

The distal end portion 252 of the coupling member 250 includes a firstend portion 251, and second end portion 253 (shown, for example in FIGS.2-5, 9-14). The second end portion 253 is configured to be disposedproximate a distal end portion 274 of the handle 270 when the stylet 230is in a first position (shown, for example in FIGS. 2, 4, 11, and 12)and is configured to be spaced apart from the distal end portion 274 ofthe handle 270 when the stylet 230 is in a second position (shown, forexample, in FIGS. 3 and 13).

The proximal end portion 254 of the coupling member 250 defines a ribbedportion 256 including a first protrusion 256 a and a second protrusion256 b (shown in FIGS. 10, 12, and 13). At least a portion of theproximal end portion 254 is configured to be slidably disposed within acavity 276 defined by the handle 270. Specifically, the ribbed portion256 is configured to engage a groove portion of the handle 270 such thatthe coupling member 250 is slidably coupled to the handle 270 (discussedin detail below).

Although the coupling member 250 is illustrated and described as beingdisposed about or fixedly coupled to the elongate member 210, othersuitable coupling configurations can be used. For example, in someembodiments, the coupling member 250 and elongate member 210 can bemonolithically constructed. In other embodiments, for example, thecoupling member 250 can be insert-molded to the elongate member 210.Furthermore, the coupling member 250 can be constructed of any suitablematerial. In one embodiment, the coupling member 250 can be constructedof a polymer. For example, the coupling member 250 can be constructed ofacrylonitrile butadiene styrene (ABS).

The distal end portion 213 of the elongate member 210 defines a secondaxis B-B, as shown, for example in FIG. 5. The distal end portion 213 ofthe elongate member 210 is configured to interact with a proximal endportion 294 of a mesh carrier 290. In the illustrated embodiment, thedistal end portion 213 of the elongate member 210 is configured to beremovably coupled to the mesh carrier 290. Specifically, as shown inFIGS. 6 and 7, the lumen 218 defined by the distal end portion 213 isconfigured to receive at least a portion of the proximal end portion 294of the mesh carrier 290 such that an inner surface 219 of the elongatemember 210 defining the lumen 218 is configured to provide aninterference or slight frictional fit with the proximal end portion 294of the mesh carrier 290 received in the lumen 218.

The elongate member 210 includes a curved portion 211 disposed betweenthe proximal end portion 212 and the distal end portion 213.Specifically, in the illustrated embodiment, the curved portion 211 isconfigured such that the second axis B-B defined by the distal endportion 213 of the elongate member is substantially orthogonal to thefirst axis A-A defined by the proximal end portion 212 of the elongatemember 210.

The elongate member 210 can be constructed of any material suitable forinsertion into a body of a patient. For example, in some embodiments,the elongate member is constructed of stainless steel. In otherembodiments, the elongate member is constructed of a polymer.

The handle 270 has a proximal end portion 272 and a distal end portion274, and is formed by a first portion (first half) 271, and a secondportion (second half) 273. The handle defines a longitudinal axis B1-B(shown in FIG. 4) and is configured to rotate about the longitudinalaxis B1-B1 in a first direction C and a second direction D as shown, forexample, in FIG. 15. The handle 270 is configured to be slidably coupledto the elongate member 210. The distal end portion 274 of the handle 270is slidably coupled to the proximal end portion 212 of the elongatemember 210 and is fixedly coupled to the proximal end portion 234 of thestylet 230.

As shown in FIGS. 2-5, the first portion 271 of the handle 270 isfixedly coupled to the second portion 273 of the handle 270 (notillustrated separately). The first and second portions 271, 273 can becoupled by any suitable coupling mechanisms. For example, the first andsecond portions 271, 273 can be coupled by an ultrasonic weld. The firstportion 271 and the second portion 273 collectively define a cavity 276configured to receive the elongate member 210. Specifically, in theillustrated embodiment, the distal end portion 274 of the handle 270defines an opening 278 in communication with the cavity 276 forreceiving at least a portion of the proximal end portion 212 of theelongate member 210 and the proximal end portion 254 of the couplingmember 250.

As shown in FIGS. 12 and 13, the first portion 271 of the handle 270defines a first groove portion 276 a, a first wall portion 277 a, and asecond wall portion 278 a. The first groove portion 276 a is configuredto slidably receive the first projection 256 a of the ribbed portion 256of the coupling member 250. The second portion 273 of the handle 270defines a second groove portion 276 b, a first wall portion 277 b, and asecond wall portion 278 b. The second groove portion 276 b is configuredto slidably receive the second projection 256 b of the ribbed portion256 of the coupling member 250. The first wall portions 277 a, 277 b areconfigured to contact the projections 256 a, 256 b when the stylet 230is in its first position (shown in FIG. 12). The second wall portions278 a, 278 b are configured to contact the projections 256 a, 256 b whenthe stylet 230 is in its second position (shown in FIG. 13) to preventremoval of the coupling member 250 from the handle 270.

The second portion 272 of the handle 270 defines an aperture 279. Theaperture 279 is configured to fixedly receive a portion of a proximalend portion 234 of the stylet 230 such that movement of the handle 270with respect to the elongate member 210, causes the stylet 230 toslidably advance or retract relative to the elongate member 210.

Although the handle 270 is illustrated as defining a contoured shape(shown in FIGS. 2-5, and 11-14), the handle 270 can define a variety ofshapes, sizes, and configurations, such as cylindrical shape. The handle270 can further be constructed of any suitable material. In someembodiments, the handle 270 can be constructed of at least one polymer.For example, the handle 270 can be constructed of acrylonitrilebutadiene styrene (ABS). In other embodiments, the handle 270 caninclude a thermoplastic elastomer material (TPE) covering a portion itsouter surface to provide a practitioner a comfortable or secure grippingarea.

The stylet 230 includes a proximal end portion 234 and a distal endportion 233. The stylet 230 is slidably disposed within the lumen 218defined by the elongate member 210. The proximal end portion 234 isfixedly coupled to the handle 270. As shown in FIGS. 10, 12, and 13, theproximal end portion 234 of the stylet 230 includes an L-shaped portionconfigured to be received within the aperture 279 defined by the handle270. Thus, as discussed above, movement of the handle 270 with respectto the elongate member 210, causes the stylet 230 to slidably advance orretract relative to the elongate member 210.

The distal end portion 233 of the stylet 230 includes a tip 235. The tip235 can be a variety of shapes. For example, in one embodiment, thestylet tip can be pointed. In another embodiment, the stylet tip can beblunt or tapered.

The stylet 230 has a first position, (i.e., an extended position) shown,for example, in FIGS. 6, 12, 18, and 19, a second position (i.e., aretracted position), shown, for example in FIGS. 3, 7, and 13. Thestylet is biased to a substantially linear configuration. When thestylet 230 is in its first position, at least a portion of the distalend portion 233 of the stylet 230 extends out of the lumen 218 at thedistal end portion 213 of the elongate member 210. The portion of thedistal end portion 233 is configured to extend through the lumen 291 andout of an opening 291 b defined by the mesh carrier (discussed in detailbelow). The portion of the distal end portion 233 is further configuredto pierce and pass through a filament 205 received by the mesh carrier290 (shown in FIGS. 18 and 19). Because the stylet 230 is biased to asubstantially linear configuration, its engagement with mesh carrier 290maintains its position within the center of the lumen 218 defined by theelongate member 210. Said another way, when the stylet 230 is in itsfirst position, the interaction between the stylet 230 and the meshcarrier 290 results in the distal end portion 233 of the stylet 230being disposed along the axis B-B defined by the distal end portion 213of the elongate member 210 (shown, for example, in FIG. 5).

As the stylet 230 is moved proximally with respect to the elongatemember 210 from its first position to its second position, the distalend portion 233 of the stylet is removed from the lumen 291 defined bythe mesh carrier 290. When the stylet 230 is in its second position, thedistal end portion 233 of stylet 230 is disposed within the lumen 218 ofthe elongate member 210. Because the stylet 230 is biased to a linearconfiguration, when it is in its second position and is no longerengaged with the mesh carrier 290, the distal end portion 233 of thestylet 230 is disposed substantially against the inner surface 219 ofthe elongate member 210 (shown, for example, in FIG. 7). Specifically,in the illustrated embodiment, when the stylet 230 is in its secondposition, the stylet 230 is disposed within the lumen 218 of theelongate member 210 such that the distal end portion 233 of the stylet230 is offset from the axis B-B defined by the distal end portion 213 ofthe elongate member 210 (shown in FIG. 7).

In some embodiments, when the stylet 230 is moved from its firstposition to its second position (i.e., when the distal end 233 of thestylet 230 is removed from the lumen 291 of the mesh carrier 290 andcontacts the inner surface 219 of the elongate member 210), a user canhear an audible click.

Once in its second position, the stylet 230 is configured to decouple orotherwise disengage the mesh carrier 290 from the elongate member 210.Because the distal end portion 233 of the stylet 230 is configured tocontact the proximal end portion 294 of the mesh carrier 290, when thestylet 230 is moved in a distal direction, it can advance the meshcarrier 290 in a distal direction out of the lumen 218 of the elongatemember 210, thereby disengaging or decoupling the mesh carrier 290 fromelongate member 210 and fixing it into bodily tissue. Specifically, thedistal end portion 233 of the stylet 230 is configured to engage themesh carrier 290 such that an orientation of a longitudinal axis A1-A1defined by the mesh carrier 290 is substantially orthogonal to thelongitudinal axis B1-B1 defined by the handle 270 coupled to theelongate member 210 (shown, for example, in FIG. 4).

The stylet 230 can be constructed of any material suitable for insertioninto a body of a patient. For example, in some embodiment, the styletcan be constructed of stainless steel. In other embodiments, the styletcan be constructed of a polymer.

FIGS. 16 and 17 are side and perspective views, respectively, of a meshcarrier 290 that can be used with the insertion device 200 describedabove. The mesh carrier 290 has a proximal end portion 294, a distal endportion 293, defines a lumen 291 (shown in FIG. 19) extending betweenthe proximal end portion 294 and the distal end portion 293, and definesan aperture 292. The proximal end portion 294 of the mesh carrier 290 isconfigured to engage or be removably coupled to at least a portion ofthe distal end portion 213 elongate member 210, shown, for example, inFIGS. 2-9, 18, and 19. In the illustrated embodiment, a portion of theproximal end portion 294 is configured to be disposed within the lumen218 of the elongate member 210 (shown, for example, in FIGS. 18 and 19)such that the lumen 291 of the mesh carrier 290 is in communication withthe lumen 218 of the elongate member 210. Said another way, the proximalend portion 294 of the mesh carrier 290 defines an opening 291 a incommunication with the lumen 291 of the mesh carrier 290. The opening291 a is in communication with the lumen 218 of the elongate member 210.Thus, the opening 291 a, and thereby the lumen 291, are configured toreceive the distal end portion 233 of the stylet 230 (shown in dashedlines in FIG. 16) from the elongate member 210.

Specifically, the mesh carrier 290 is coupled to the elongate member 210by an interference or frictional fit. Although, the proximal end portion294 of the mesh carrier 290 defines a substantially smooth outersurface, in other embodiments, the outer surface of the proximal endportion 294 can include a textured surface. For example, in someembodiments, the outer surface of the proximal end of the mesh carriercan include at least one rib or ridge (not shown) configured to helpprovide an interference or frictional fit with the lumen of the elongatemember.

The proximal end portion 294 of the mesh carrier 290 includesprotrusions 296, 297 disposed about a periphery of the mesh carrier 290approximately 180 degrees apart (shown in FIGS. 16 and 17). In someembodiments, the protrusions 296, 297 are configured to contact thedistal end portion 213 of the elongate member 210 when the mesh carrier290 is coupled to the elongate member 210, as shown in FIGS. 18 and 19.Protrusions 296, 297 are further configured to help anchor at least aportion of the mesh carrier 290 in the body of the patient once the meshcarrier 290 is placed within the bodily tissue.

The proximal end portion 294 of the mesh carrier 290 further includes afirst anchor portion 299 (shown, for example, in FIGS. 16 and 17)configured to help anchor the mesh carrier 290 in the bodily tissue ofthe patient once the mesh carrier 290 is placed within the bodilytissue. The first anchor portion 299 includes projections 299 a and 299b disposed about the periphery of the proximal end portion 294 of themesh carrier 290 approximately 180 degrees apart.

The distal end portion 293 of the mesh carrier 290 includes a secondanchor portion 298 (shown, for example, in FIGS. 16 and 17) configuredto help anchor at least a portion of the mesh carrier 290 in the body ofthe patient once the mesh carrier 290 is placed within the bodilytissue. The second anchor portion 298 includes projections 298 a and 298b disposed about the periphery of the distal end portion 293 of the meshcarrier 290.

The first anchor portion 299 (i.e., projections 299 a, 299 b) and thesecond anchor portion 298 (i.e., projections 298 a, 298 b) areconfigured to help prevent the mesh carrier 290 from regressing throughthe bodily tissue in which it is placed. For example, in oneapplication, the first anchor portion 299 and the second anchor portion298 are configured to retain or anchor the mesh carrier 290 in one ofthe obturator internus or obturator externus muscles.

As illustrated in FIG. 19, the aperture 292 defined by the mesh carrier290 is configured to receive at least a portion of the filament 205. Theaperture 292 is configured to allow the filament 205 to be threaded orpassed through the mesh carrier 290 via the aperture 292. The aperture292 can be configured to allow movement or adjustment of at least aportion of the filament 205 through the aperture 292. For example, insome embodiments, the filament 205 can be movable through the aperture292 in only a first direction (i.e. one way). In other embodiments, thefilament 205 can be movable through the aperture 292 in the firstdirection and in a second direction that is different than the firstdirection. The aperture 292 can also be configured to provide little orno resistance to movement or adjustment of the filament 205. Forexample, the aperture 292 can have an opening greater in size than thewidth or thickness of the filament 205. In such an embodiment, thefilament 205 can readily be moved through the aperture 292, meetingminimal or no resistance.

In an one embodiment, the aperture 292 is configured to provide africtional fit with the filament 205 passed through (or received within)the aperture 292. For example, the aperture 292 can be configured to beslightly smaller (or narrower) than the thickness of the filament 205.In such an embodiment, a force must be applied to move the filament 205through the aperture 292. In yet another embodiment, the aperture 292provides substantial resistance to movement or adjustment of thefilament 205, such that the filament 205 is substantially fixed withinthe aperture 292.

The aperture 292 can have any suitable size or shape configured toreceive the filament 205, for example the shape can be a U-shape (asillustrated in FIGS. 16 and 17), circle, square, rectangle star,triangle, trapezoid, or any other shape configured to receive afilament.

The mesh carrier 290 can be constructed of any material suitable forimplantation into bodily tissue. For example, the mesh carrier 290 canbe constructed of implantable grade polypropylene, implantable grademetal, a polymer, a biocompatible material, or any combination thereof.Suitable biocompatible materials include bioabsorbable, cadaveric, andbovine materials.

Although the mesh carrier 290 is illustrated and described as beingreceived by the elongate member 210, it should be understood that othersuitable configurations can be used. For example, the mesh carrier canbe configured to receive a portion of the elongate member to couple themesh carrier to the elongate member. Specifically, at least a portion ofan outer surface of the elongate member can be configured to provide aninterference or slight frictional fit with a mesh carrier when at leasta portion of the elongate member is received in a lumen of the meshcarrier. Said another way, a portion of the mesh carrier can beconfigured to be disposed over a portion of the elongate member. In suchan embodiment, the elongate member can include a sheath disposed aboutan outer surface of the elongate member for disengaging the mesh carrier(discussed in more detail below).

Although the mesh carrier 209 is illustrated and described above asdefining a lumen 291 and an opening 291 a configured to receive thedistal end portion 233 of the stylet 230, other suitable configurationscan be used. For example, the proximal end portion of the mesh carriercan define a substantially solid surface configured to contact thedistal end portion of the stylet. Specifically, in such embodiments, thestyle is moved in a distal direction, such that the distal end portionof the stylet moves distally within the lumen of the elongate member andcontacts the proximal end portion of the mesh carrier to decouple orotherwise disengage the mesh carrier from the elongate member.

In some embodiments, the insertion device 200 described above, can beused to insert a plurality of mesh carriers within bodily tissue of apatient. As shown in FIG. 20, the insertion device 200 can be used toinsert a first mesh carrier 290 and a second mesh carrier 390 intobodily tissue T of a patient. FIG. 20 illustrates an example of thefirst mesh carrier 290 and the second mesh carrier 390 anchored inbodily tissue T of the pelvic region of a patient. The filament 205extends between the first mesh carrier 290 and the second mesh carrier390 to provide support to the target tissue T or organ. In theillustrated embodiment, the filament 205 extends below the urethra andforms a sling to provide support to the urethra.

The filaments and implants as discussed above can be constructed of manydifferent suitable materials and have many different suitableconfigurations. For example, in some embodiments, a polymer mesh implantis used, which can be used to support the urethra. In other embodiments,a polyform material can be used.

In some embodiments, a portion of the filament can be reinforced, suchas with a reinforcing material. The reinforcing material, or reinforcedportion of the filament, can be configured to assist in suspending orsupporting the bodily tissue or organ. In one embodiment, the filamentcan be reinforced by a suture.

In some embodiments, at least a portion of the filament can includetangs or a tanged portion to grip or attach to a portion of bodilytissue. The terms “tanged” or “tangs” as used herein mean roughened orjagged edges or areas, such as can result from cutting a woven or knitmesh material or filament. The tangs enhance anchoring of the filamentwithin bodily tissue, such as pubo-urethral tissue. In one embodiment,the filament includes tangs on an edge along an entire length of thefilament. In another embodiment, tangs are only on the end portions ofthe filament.

In other embodiments, the filament is untanged or detanged, such as byheating the tangs on a polymer mesh so that they fuse and bead up toform a smooth finish.

In some embodiments, the filament includes a coating. For example, thefilament can include a polymeric coating. In another example, thefilament can include a therapeutic agent coating.

In yet other embodiments, the filament can be porous. A porous filamentdefines openings, or pores, in the filament or between threads ofmaterial forming the filament. For example, in one embodiment, thefilament is a mesh. The filament can be a micro-porous mesh in which theopenings, or pores, are small.

Although the stylet 230 as illustrated in FIGS. 2-15, 18, and 19 isslidably disposed within the lumen 218 of the elongate member 210, itshould be understood that other configurations are possible. As shown inFIGS. 21-23, the stylet 330 can be fixedly retained within the elongatemember 310. For example, the elongate member 310 and the stylet 330 canbe formed as one component such that they do not move relative to oneanother. In such embodiments, the elongate member 310 is slidablydisposed within a lumen 341 defined by a sheath 340. Said another way,the sheath 340 is slidably disposed about an outer surface 319 of theelongate member 310 for disengaging the mesh carrier 490 from theelongate member 310.

The proximal end portion 494 of the mesh carrier 490, in suchembodiments, defines a cavity C configured to receive at least a portionthe distal end portion 313 of the elongate member 310. Specifically, aninner surface 494 a of the proximal end portion 494 of the mesh carrier490, which defines the cavity C is configured to provide an interferenceor slight frictional fit with an outer surface 319 of the elongatemember 310 received in the cavity C. In such embodiments, when thestylet 330 (and elongate member 310) is in its first configuration, thestylet 230 is configured such that a portion of the distal end portion333 the stylet 330 extends through the lumen 491 of the mesh carrier 490and out the opening 491 b, as shown in FIGS. 21 and 22. As the stylet330 moves proximally with respect to the sheath 340 from its firstposition to its second position, the distal end portion 343 of thesheath 340 contacts a portion of the proximal end portion 494 of themesh carrier 490 and prevents proximal movement of the mesh carrier 490.When the stylet 330 is in its second position, as illustrated, forexample, in FIG. 23, the elongate member 310 and the distal end portion333 of the stylet 330 is disposed within the lumen 341 of the sheath340. Specifically, in the illustrated embodiment, when the stylet 330 ismoved proximally from its first position, the distal end portion 343 ofthe sheath 340 contacts the proximal end portion 494 of the mesh carrier490 maintaining its location within bodily tissue. The mesh carrier 490is thereby decoupled or removed from the distal end portion 313 of theelongate member 310 and is released in bodily tissue.

In some embodiments, an inner surface of the proximal end 494 of themesh carrier 490 can include at least one rib or ridge configured tohelp provide the interference or frictional fit with the outer surface319 of the elongate member 310.

Although the insertion devices are illustrated and described above asincluding an elongate member having a radius of curvature such that theproximal end portion of the elongate member defines an axissubstantially orthogonal to an axis defined by the distal end portion ofthe elongate member, other suitable configurations can be used. Forexample, the axis defined by the proximal end portion of the elongatemember and the axis defined by the distal end portion of the elongatemember can define an angle greater than or less than 90 degrees relativeto one another.

FIG. 24 is a flowchart of a method 500 for delivering a mesh carrierinto bodily tissue of a patient using an insertion device according toan embodiment of the invention.

At 510, the mesh carrier is coupled to the stylet of the insertiondevice. For example, the proximal end portion of the mesh carrier isengaged with the distal end portion of the elongate member. For example,in some embodiments, a portion of the proximal end portion of the meshcarrier is received within the lumen defined by the distal end portionof the elongate member. In other embodiments, the portion of theproximal end portion of the mesh carrier is configured to receive aportion of the distal end portion of the elongate member.

In some embodiments at least a portion of the filament is inserted intothe aperture defined by the mesh carrier prior to the coupling of themesh carrier to the elongate member. For example, at least a portion ofthe filament is inserted into the aperture such that at least a portionof the filament is substantially orthogonal to the lumen defined by themesh carrier.

In some embodiments, the mesh carrier is coupled to or engaged with theelongate member when the stylet is in its first position. In suchembodiments, the stylet passes through the filament inserted into theaperture defined by the mesh carrier and retains the filament within theaperture of the mesh carrier.

At 520, the insertion device is inserted into a body of a patient. Forexample, in one embodiment, the insertion device is inserted into thebody of the patient through an incision made in bodily tissue. In aprocedure for urinary incontinence, one approach for inserting theinsertion device into the body of the patient includes making anincision in the vaginal wall and inserting a portion of the insertiondevice through the vaginal incision. The portion of the insertion deviceis then directed towards the desired bodily tissue. The curved elongatemember is useful in navigating around certain bodily structures to reachthe desired bodily tissue.

At 530, the mesh carrier is positioned proximate to a desired portion ofbodily tissue, and the mesh carrier is inserted into the bodily tissue.For example, in a procedure for female urinary incontinence, the meshcarrier is inserted into one of the obturator internus or obturatorexternus muscles.

At 540, the mesh carrier is removed from the lumen at the distal endportion of the elongate member. Specifically, the stylet is moved fromits first position to its second position, and then from its secondposition to its first position. For example, in one embodiment, as shownin FIG. 7, the stylet is moved in a proximal direction, from its firstposition to its second position, such that the distal end portion of thestylet is withdrawn from the lumen of the mesh carrier and the filament.By withdrawing the distal end portion of the stylet from the lumen ofthe mesh carrier and disposing it within the lumen of the elongatemember, the distal end portion of the stylet becomes offset from an axisdefined by the distal end portion of elongate member and contacts theinner wall of the elongate member. The distal end portion of the styletis configured to contact a portion of the proximal end portion of themesh carrier when in its second configuration. In one procedure, apractitioner concurrently pulls the handle in a proximal direction whileholding the coupling member substantially stationary. In anotherprocedure, the practitioner concurrently pushes the coupling member in adistal direction, thereby moving the elongate member in a distaldirection, while holding the handle substantially stationary.

To remove the mesh carrier, the stylet is moved in a distal directionfrom its first position to its second position such that the distal endportion of the stylet concurrently moves the mesh carrier in a distaldirection thereby removing the mesh carrier from the lumen at the distalend portion of the elongate member. Thus, the mesh carrier is decoupledfrom the elongate member, and the mesh carrier and filament are fixedwithin the bodily tissue.

At 550, the filament is moved, or adjusted, through the aperture of themesh carrier. In one embodiment, the filament is moved or adjustedthrough the aperture in a first direction. For example, the filament ismoved in the first direction to increase tension in the filament. Inanother example, the filament is moved in the first direction todecrease the length of the filament, for example, to shorten the lengthof the filament that will support or suspend a target organ or tissue.

In some embodiments, the filament is moved, or adjusted, through theaperture in a second direction different than the first direction. Forexample, the filament is moved in the second direction to decrease thetension in the filament. In one embodiment, the filament is moved in thesecond direction to increase the length of the filament suspendedbetween a first mesh carrier and a second mesh carrier. For example, thefilament is moved in the second direction to alter the position of theorgan or tissue being supported or suspended, such as by increasing thelength of filament between a first mesh carrier and a second meshcarrier and lowering the organ or tissue to a more anatomically correctposition.

In another example, the filament is moved in the second direction tocreate or increase a space between the filament and the organ or tissueto be supported or suspended. For example, in a treatment for urinaryincontinence, the filament can be adjusted to leave a space between thefilament and the urethra (the organ to be supported). The space existsbetween the filament and the urethra when the patient is in oneposition. When the patient moves to another position, such as an uprightposition, the urethra shifts to occupy the space and is then supportedby the filament.

In one embodiment, the filament is manually moved by a practitioner. Inanother embodiment, the practitioner grips at least a portion of thefilament with a medical instrument, such as forceps, to move thefilament.

Adjustment of the filament through the aperture in the first directionor in the second direction different than the first direction can berepeated until the desired tension or length of filament is achieved.For example, a practitioner can alternatively move the filament in thefirst direction to increase tension and move the filament in the seconddirection to decrease tension until the desired tension is achieved.

In some embodiments, the filament can be trimmed to a preferred lengthonce the desired tension is achieved or once the mesh carrier isdisengaged from the elongate member and delivered into bodily tissue.

At 560, the insertion device is withdrawn from the body of the patient.Although activities of a method of delivering a mesh carrier into bodilytissue have been illustrated and described in one order, each activityis not required for delivery of a mesh carrier into bodily tissue. Forexample, in some embodiments, the filament can be adjusted in only onedirection through the aperture of the mesh carrier. In another example,the filament is not adjusted through the aperture of the mesh carrier atall.

A method for delivering a mesh carrier (and filament or implant) intobodily tissue of a patient can include delivering more than one meshcarrier for securing a filament to bodily tissue. For example, in oneembodiment, as illustrated in FIG. 20 two mesh carriers are deliveredinto bodily tissue of the patient. Alternatively, three, four, or moremesh carriers are delivered into bodily tissue of the patient). In anembodiment with two or more mesh carriers, the first mesh carrier isdelivered as described above. It is not necessary, however, to adjustthe filament received within the aperture of the first mesh carrier. Thelength or tension of the filament can be adjusted with regard to anyoneor more of the second, third, fourth, or more mesh carriers. The lengthbetween fixed mesh carriers can be any suitable length. For example, thelength between fixed mesh carriers can be about 8 centimeters, 10centimeters, 12 centimeters, 14 centimeters, 16 centimeters, or longeror shorter. In an embodiment with two or more mesh carriers, each meshcarrier is delivered in a substantially similar manner as describedabove with respect to the first mesh carrier. For ease of operation, thefilament can be inserted into the aperture of each mesh carrier beforethe first mesh carrier is delivered into bodily tissue.

FIGS. 25-27 illustrate locations within the female pelvic region inwhich an implant can be placed using the method of delivery as discussedabove with respect to FIG. 24. In some embodiments, as illustrated inFIG. 25, an implant can be placed within the body through the obturatormembrane and into the externus muscle as indicated by E₁ and E₂. Byinserting the insertion device through the obturator membrane and intothe externus muscle, the insertion device can be directed in a lateraldirection to form a hammock configuration. Specifically, by fixing theimplant (i.e., mesh carriers, filament, etc.) in the E₁ location (shownin FIG. 26) and the contra lateral side, the implant will form thehammock configuration. In some embodiments, the hammock configurationcan be achieved by placing the mesh carriers in a muscle at a locationI₁. Alternatively, the insertion device can be moved in a directiontoward a shoulder blade of a patient to provide a “U” shapedconfiguration. Specifically, by fixing the implant in the E₂ location(shown in FIG. 27) and the contra lateral side, the implant will formthe “U” shaped configuration.

Although the “U” shaped implant is achieved when placed within the bodythrough the obturator membrane and into the externus muscle, the “U”shaped implant configuration, however, can also be achieved via aretro-pubic approach by placing the mesh carriers at the locationsmarked R1 and R2.

When fixing the implant to tissue, an insertion device (for example,insertion device 200, including stylet 230 and mesh carrier 290, asdiscussed above with respect to FIGS. 2-19), is inserted through thevagina V and is advanced along and around the ischiopubic ramus IR,shown in FIG. 4, until the tip of the stylet is proximate the obturatormembrane. The handle of the insertion device is rotated, in either the Cdirection or the D direction (shown in FIG. 15) such that the tip of thestylet 230 of the insertion device 200 is aimed at the desired tissue.The handle can also be pivoted in a direction H (shown in FIG. 26).Alternatively, the tip of the stylet 230 of the insertion device 200 canbe aimed by pivoting the handle 270 to a location A, as shown in FIG. 4.The handle 270 is then pivoted such that the axis B1-B1 defined by thehandle 270 (shown, for example, in FIG. 4) is parallel to the midline Mof the patient (shown in FIG. 25). A force in a direction F (shown inFIGS. 4 and 27) is applied to the handle 270 such that the tip of thestylet 230 and the mesh carrier 290 is advanced through the obturatormembrane OM and into the externus muscle, and such that the axis B1-B1remains substantially parallel to the midline M of the patient. Theelongate member 210 of the insertion device 200 contacts the ischiopubicramus IR (shown in FIG. 4) such that it prevents further lateralmovement of the stylet tip into the externus muscle.

In one embodiment, as shown in FIG. 26, the mesh carrier 290 is insertedin the E₁ location. In such an embodiment, a force of gravity G due to aweight of the handle 270 causes the handle 270 to rotate in a directionH such that inadvertent removal of the mesh carrier 290 due to theweight of the handle 270 is unlikely. In another embodiment, as shown inFIG. 27, the mesh carrier 290 is inserted in the E₂ location. In thisinstance, the force of gravity G can cause the handle 270 to pivot suchthat the axis B1-B1 defined by the handle 270 is substantially offsetfrom the midline M of the patient. The force of gravity G can also causethe handle 270 to rotate in a direction K about axis B-B defined by thedistal end portion of the elongate member 210 of the insertion device200. In such an embodiment, the force of gravity G due to the weight ofthe handle 270 can affect the holding strength of the mesh carrier 290.Therefore, in some embodiments, the possibility of inadvertent removalof the mesh carrier 290 can be reduced. For example, in suchembodiments, the cavity defined by the handle 270, as discussed indetail above, can be defined such that the handle 270 has a minimalweight.

In one embodiment, an insertion device includes an elongate memberhaving a proximal end portion, a distal end portion, and defining alumen therethrough. The elongate member includes a curved portionbetween the proximal end portion and the distal end portion. The distalend portion is configured to be removably coupled to a mesh carrier. Theproximal end portion includes a handle defining a longitudinal axis. Theinsertion device also includes a stylet that has a proximal end portion,a distal end portion and is configured to move from a first position toa second position with respect to the elongate member. The stylet isconfigured to engage the mesh carrier to remove the mesh carrier fromthe elongate member such that a longitudinal axis defined by the meshcarrier is substantially orthogonal to the longitudinal axis defined bythe handle.

In one embodiment, the distal end portion of the stylet is configured toextend outside of the distal end portion of the elongate member when thestylet is in its first position.

In another embodiment, the distal end portion of the stylet isconfigured to contact a proximal end portion of a mesh carrier when thestylet is moved from its second position to its first position.

In one embodiment, a longitudinal axis defined by the proximal endportion of the elongate member is substantially orthogonal to alongitudinal axis defined by the distal end portion of the elongatemember. In another embodiment, the curved portion of the elongate memberhas a radius of curvature of approximately 1.1 inches.

In one embodiment, the lumen of distal end portion of elongate member isconfigured receive a portion of the mesh carrier and to provide aninterference fit with the mesh carrier.

In one embodiment, the elongate member includes stainless steel. Inanother embodiment, the handle is slidably coupled to the proximal endportion of the elongate member and the handle has at least one groove.The proximal end of the elongate member includes a coupling member thathas at least one protrusion configured to engage the at least onegroove.

In one embodiment, the insertion device includes a coupling membercoupled to the proximal end portion of the elongate member. The couplingportion defines at least one protrusion.

In another embodiment, the insertion device includes a coupling membercoupled to the proximal end portion of the elongate member. The couplingmember includes a coupling portion extending proximally therefrom. Thecoupling portion defining at least one protrusion. The handle isconfigured to engage the at least one protrusion of the couplingportion.

In another embodiment, an insertion device includes an elongate memberhaving a proximal end portion, a distal end portion, and defining alumen therethrough. An axis defined by the proximal end portion of theelongate member is substantially orthogonal to an axis defined by thedistal end portion of the elongate member. The insertion devise alsoincludes a stylet having a proximal end portion and a distal endportion. At least a portion of the stylet is disposed within the lumenof the elongate member. The stylet is slidably coupled to the elongatemember such that the stylet is configured to move from a first positionto a second position with respect to the elongate member.

In one embodiment, the elongate member includes a curved portion thathas a radius of curvature of 1.1 inches.

In another embodiment, the distal end portion of the elongate member isconfigured to be removably coupled to a mesh carrier. In yet anotherembodiment, the lumen defined by the elongate member is configured toreceive a portion of a mesh carrier and to provide an interference fitwith the mesh carrier.

In one embodiment, the stylet is biased to a linear configuration.

In another embodiment, the insertion device also includes a couplingmember disposed about the proximal end portion of the elongate member.The coupling member has at least one protrusion. The handle has at leastone groove to engage the at least one protrusion of the coupling member.

In one embodiment, the elongate member includes stainless steel.

In one embodiment, the distal end portion of the stylet is configured topierce a filament received in a mesh carrier when the insertion deviceis in its first configuration. In another embodiment, the distal endportion of the stylet is configured to decouple a mesh carrier from theelongate member when the stylet is moved from its second position to itsfirst position.

A method of inserting a mesh carrier into a body of a patient includes(1) coupling the mesh carrier to a distal end portion of an elongatemember of an insertion device; (2) inserting the insertion device intothe body; (3) decoupling the mesh carrier such that a longitudinal axisdefined by the mesh carrier is substantially orthogonal to an axisdefined by the proximal end portion of the elongate member; and (4)removing the insertion device from the body.

In one embodiment, the coupling of the mesh carrier includes moving thestylet to its first position such that a distal end portion of a styletextends beyond the distal end portion of the elongate member. In anotherembodiment, the decoupling of the mesh carrier includes moving thestylet from its first position to a second position. In yet anotherembodiment, the moving of the stylet to its second position includesmoving the stylet in a proximal direction.

In one embodiment, the method includes inserting a filament into anaperture defined by the mesh carrier prior to coupling the mesh carrierto the stylet. In another embodiment, the method includes inserting afilament into an aperture defined by the mesh carrier prior to couplingthe mesh carrier to the stylet.

In one embodiment, the decoupling of the mesh carrier includes movingthe stylet from its second position to its first position such that thedistal end of the stylet contacts a proximal end portion of the meshcarrier. In another embodiment, the moving of the stylet to its firstposition includes moving the stylet in a distal direction.

In one embodiment, the method includes coupling a second mesh carrier tothe distal end portion of the elongate member when the stylet is in itsfirst position and inserting the insertion device into the body of thepatient. In another embodiment, the method includes moving the styletfrom its second position to its first position to decouple the secondmesh carrier at a second location, wherein an orientation of the secondmesh carrier is orthogonal to the axis defined by the proximal end ofthe elongate member, and removing the insertion device from the body.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Thus, the breadth and scope of the inventionshould not be limited by any of the above-described embodiments, butshould be defined only in accordance with the following claims and theirequivalents. While the invention has been particularly shown anddescribed with reference to specific embodiments thereof, it will beunderstood that various changes in form and details may be made.

The previous description of the embodiments is provided to enable anyperson skilled in the art to make or use the invention. While theinvention has been particularly shown and described with reference toembodiments thereof, it will be understood by those skilled in art thatvarious changes in form and details may be made. For example, a deliveryinstrument can include various combinations and sub-combinations of thevarious embodiments described herein.

1. An insertion device, comprising: an elongate member having a proximalend portion, a distal end portion, and defining a lumen therethrough,the elongate member including a curved portion between the proximal endportion and the distal end portion, the distal end portion configured toremovably couple a tissue anchor thereto, the proximal end portionincluding a handle defining a longitudinal axis; and a stylet having aproximal end portion, a distal end portion and being configured to movefrom a first position to a second position with respect to the elongatemember, the stylet configured to engage the tissue anchor to remove thetissue anchor from the elongate member such that a longitudinal axisdefined by the tissue anchor is substantially orthogonal to thelongitudinal axis defined by the handle.
 2. The insertion device ofclaim 1, wherein the distal end portion of the stylet is configured toextend outside of the distal end portion of the elongate member when thestylet is in its first position.
 3. The insertion device of claim 1,wherein the distal end portion of the stylet is configured to contact aproximal end portion of a tissue anchor when the stylet is moved fromits second position to its first position.
 4. The insertion device ofclaim 1, wherein a longitudinal axis defined by the proximal end portionof the elongate member is substantially orthogonal to a longitudinalaxis defined by the distal end portion of the elongate member.
 5. Theinsertion device of claim 1, wherein the curved portion of the elongatemember has a radius of curvature of approximately 1.1 inches.
 6. Theinsertion device of claim 1, the handle being slidably coupled to theproximal end portion of the elongate member, the handle having at leastone groove, the proximal end of the elongate member includes a couplingmember having at least one protrusion configured to engage the at leastone groove.
 7. The insertion device of claim 1, further comprising: acoupling member coupled to the proximal end portion of the elongatemember, the coupling member including a coupling portion extendingproximally therefrom, the coupling portion defining at least oneprotrusion, wherein the handle is configured to engage the at least oneprotrusion of the coupling portion.
 8. An insertion device, comprising:an elongate member having a proximal end portion, a distal end portion,and defining a lumen therethrough, wherein an axis defined by theproximal end portion of the elongate member is substantially orthogonalto an axis defined by the distal end portion of the elongate member; anda stylet having a proximal end portion and a distal end portion, atleast a portion of the stylet disposed within the lumen of the elongatemember, the stylet being slidably coupled to the elongate member suchthat the stylet is configured to move from a first position to a secondposition with respect to the elongate member.
 9. The insertion device ofclaim 8, the distal end portion of the elongate member is configured tobe removably coupled to a tissue anchor.
 10. The insertion device ofclaim 8, wherein the stylet is biased to a linear configuration.
 11. Theinsertion device of claim 8, further comprising: coupling memberdisposed about the proximal end portion of the elongate member, thecoupling member having at least one protrusion, the handle having atleast one groove to engage the at least one protrusion of the couplingmember.
 12. The insertion device of claim 8, wherein the distal endportion of the stylet is configured to pierce a filament received in atissue anchor when the insertion device is in its first configuration.13. A method of inserting a tissue anchor into a body of a patient,comprising: coupling the tissue anchor to a distal end portion of anelongate member of an insertion device; inserting the insertion deviceinto the body; decoupling the tissue anchor such that a longitudinalaxis defined by the tissue anchor is substantially orthogonal to an axisdefined by the proximal end portion of the elongate member; and removingthe insertion device from the body.
 14. The method of claim 13, whereinthe coupling of the tissue anchor includes moving the stylet to itsfirst position such that a distal end portion of a stylet extends beyondthe distal end portion of the elongate member.
 15. The method of claim13, wherein the decoupling of the tissue anchor includes moving thestylet from its first position to a second position.
 16. The method ofclaim 13, further comprising: inserting a filament into an aperturedefined by the tissue anchor prior to coupling the tissue anchor to thestylet.
 17. The method of claim 13, wherein the decoupling of the tissueanchor includes moving the stylet from its second position to its firstposition such that the distal end of the stylet contacts a proximal endportion of the tissue anchor.
 18. The method of claim 13, wherein themoving of the stylet to its first position includes moving the stylet ina distal direction.
 19. The method of claim 13, further comprising:coupling a second tissue anchor to the distal end portion of theelongate member when the stylet is in its first position; and insertingthe insertion device into the body of the patient.
 20. The method ofclaim 13, further comprising: moving the stylet from its second positionto its first position to decouple the second tissue anchor at a secondlocation, wherein an orientation of the second tissue anchor isorthogonal to the axis defined by the proximal end of the elongatemember; and removing the insertion device from the body.